Olema Oncology
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer. Our follow‑on product candidate, OP-3136, is a potent KAT6 inhibitor with best‑in‑class potential.
About the Role
The Director of Analytical Development reports to the Senior Director, Analytical Chemistry and is responsible for driving progress of early and late‑stage molecules by delivering phase‑appropriate analytical methods and validation. The role drives method innovation, ensures alignment with regulatory expectations, and partners cross‑functionally with process development, formulation, CMC, and quality activities. The Director operates in a fast‑paced, growth‑stage biotech environment. Oversee analytical method development, qualification, and validation for starting materials, in‑process control, process intermediates, drug substances and drug products Conduct analytical technical review of method validation/qualification protocols, data, and reports generated at CDMOs for drug substances and drug products Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products Manage stability programs, monitor trending stability data, and establish retest periods or shelf lives for drug substances or drug products Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions Represent Analytical Chemistry at internal and external scientific team meetings as needed Remain current with state‑of‑the‑art approaches and applicable global regulations and industry standards Ideal Candidate Profile
Knowledge and experience
PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small‑molecule drug substance and drug product analytical development and quality control, including late‑stage clinical development and preparation for product registration Minimum of 5 years direct leadership experience managing internal and external teams Expertise in cGMP, ICH, and FDA regulations/guidance Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.) Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones Experience partnering with cross‑functional teams to provide analytical development leadership across programs and projects Demonstrated interpersonal skills, including strong oral and written communication abilities Attributes
A high level of curiosity, intelligence, ability to work independently, “can‑do” attitude, and ability to work cross‑functionally; strong initiative and follow‑through are essential Aspires to the highest of scientific and ethical standards Ability to multi‑task and shift priorities rapidly to meet tight deadlines Keen to improve processes and overcome inefficiencies The base pay range for this position is expected to be
$215,000 - $230,000
annually, with additional equity, bonus, and benefits. Important Information
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and give them a platform to develop their long‑term careers. A summary of benefits is available for all applicants. Fraud Alert
Olema does not accept agency resumes and is not responsible for any fees related to unsolicited resumes. Olema does not conduct interviews via text message or messaging platforms, does not ask you to download anything as part of your interview, will never request any form of payment, and does not make job offers without an in‑person interview. Please verify official communications come from @olema.com or oma.com. Contrary communications are fraudulent.
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The Director of Analytical Development reports to the Senior Director, Analytical Chemistry and is responsible for driving progress of early and late‑stage molecules by delivering phase‑appropriate analytical methods and validation. The role drives method innovation, ensures alignment with regulatory expectations, and partners cross‑functionally with process development, formulation, CMC, and quality activities. The Director operates in a fast‑paced, growth‑stage biotech environment. Oversee analytical method development, qualification, and validation for starting materials, in‑process control, process intermediates, drug substances and drug products Conduct analytical technical review of method validation/qualification protocols, data, and reports generated at CDMOs for drug substances and drug products Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products Manage stability programs, monitor trending stability data, and establish retest periods or shelf lives for drug substances or drug products Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions Represent Analytical Chemistry at internal and external scientific team meetings as needed Remain current with state‑of‑the‑art approaches and applicable global regulations and industry standards Ideal Candidate Profile
Knowledge and experience
PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small‑molecule drug substance and drug product analytical development and quality control, including late‑stage clinical development and preparation for product registration Minimum of 5 years direct leadership experience managing internal and external teams Expertise in cGMP, ICH, and FDA regulations/guidance Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.) Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones Experience partnering with cross‑functional teams to provide analytical development leadership across programs and projects Demonstrated interpersonal skills, including strong oral and written communication abilities Attributes
A high level of curiosity, intelligence, ability to work independently, “can‑do” attitude, and ability to work cross‑functionally; strong initiative and follow‑through are essential Aspires to the highest of scientific and ethical standards Ability to multi‑task and shift priorities rapidly to meet tight deadlines Keen to improve processes and overcome inefficiencies The base pay range for this position is expected to be
$215,000 - $230,000
annually, with additional equity, bonus, and benefits. Important Information
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and give them a platform to develop their long‑term careers. A summary of benefits is available for all applicants. Fraud Alert
Olema does not accept agency resumes and is not responsible for any fees related to unsolicited resumes. Olema does not conduct interviews via text message or messaging platforms, does not ask you to download anything as part of your interview, will never request any form of payment, and does not make job offers without an in‑person interview. Please verify official communications come from @olema.com or oma.com. Contrary communications are fraudulent.
#J-18808-Ljbffr